Non-allergic Rhinitis. Clinical Trial
Official title:
A Randomized Study (With Active Treatment in Both Treatment Groups) to Evaluate How a New Vibration Treatment in the Nose in Patients With Non-allergic Rhinitis Can be Done as Convenient as Possible to the Patient
| Verified date | May 2015 |
| Source | Halmstad County Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patients with persistent (>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days - Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3) - Male or female 18 - 65 years - Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination - Willing and able to provide written informed consent prior to participation in the clinical investigation - Willing and able to comply with all study related procedure Exclusion Criteria: - Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST(radioallergosorbent test) - Ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1) - Systemic steroid treatment less than 4 weeks before the inclusion in the study - Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture - History of frequent nose bleeds or a condition that increases the risk of excessive bleeding - Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination - Current malignancy of any kind - Known allergy to polyvinylchloride or medicinal liquid paraffin - Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk - Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region - Previous treated with radiation on the face, head or neck regions - Female patients who are pregnant or nursing, or become pregnant at any time from first visit at ENT(Ear, Nose and Throat) - clinic until treatment day (second visit) - Female patients: unwilling to use adequate contraceptive between first and last visit - Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Ear, Nose and Throat Dept, Halmstad County Hospital | Halmstad |
| Lead Sponsor | Collaborator |
|---|---|
| Halmstad County Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Peak Nasal Inspiratory Flow (PNIF) | To evaluate if treatment effect (assessed 15 minutes before treatment and 14 days after treatment) by PNIF is different between treatment groups. | Baseline, day 14 | No |
| Primary | Pain score on the Visual Analogue Scale | To evaluate whether patient´s self-administration of catheter into nasal cavity is associated with a different degree of patient-reported pain on Visual Analogue Scales (VAS) compared to when administered by a health professional. | Five seconds after placement of catheter in nasal cavity | No |
| Secondary | Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire | To evaluate if treatment effect (assessed 15 minutes before treatment and 14 days after treatment) by SNOT-22 is different between treatment groups. | Baseline, day 14 | No |